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by Core Business Solutions Co-Founder & President
Scott Dawson
AS9100 IN A SMALL BUSINESS
103-42518
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In the aviation, space and defense industries, quality, product safety and on-time delivery are paramount. The major original equipment manufacturers (OEMs) work with a global supply-chain made up of manufacturers and distributors which includes thousands of small businesses. To ensure quality, safety and on-time delivery of the millions of components, assemblies, software, etc. that make up the aircraft, vehicles and other OEM systems used in the field, the AS9100 standard has been developed.
Your company may be required to become AS9100 certified to meet a current or future customer contract. If that is the case, there are several steps needed to complete and maintain the certification. Certification is issued by a third-party Registrar following a certification audit. For you to be successful, everyone in your company will need to be involved. This whitepaper explains the basics of what is needed to get certified, including steps to get started.
Aviation Space Defense
Contents
Introduction .............................................................. 4
Process Approach ................................................... 6
Operational Risk Management.............................. 7
Context of the Organization ................................... 8
Leadership ................................................................ 9
Planning .................................................................. 10
Support & Resources.............................................. 11
Customer Focus ...................................................... 12
Operations Control ................................................ 13
Business Processes .................................................. 14
Performance Evaluation & Improvement ........... 15
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Introduction
What is AS9100?
It is a global quality standard that defines minimum requirements for a company’s processes to enhance safety of its products and performance for its customers. AS9100 is written for companies in the aviation, space and defense industries. It is based on the ISO 9001 standard used in other industries.
Who wrote it?
An industry group called “IAQG” (International Aerospace Quality Group) with representatives from aviation, space and defense industries.
Who uses it?
Manufacturing and services companies throughout the aviation, space and defense industries from the major OEMs throughout all levels of the supply-chain. (Note: a separate standard – AS9120 – is available for distributors).
What are the benefits?
Being compliant to the standard helps a company to be efficient and competitive. Being AS9100 certified allows a company to qualify for contracts that include this requirement.
Who issues the certificate?
An independent, third-party auditor called a “Registrar” (or certification body) conducts an initial certification audit to confirm your company is compliant to the AS9100 requirements. Following a successful audit, the Registrar issues the AS9100 certificate. To maintain certification, annual surveillance audits are conducted to confirm continued compliance and ongoing improvement.
Who needs to be involved?
All managers and employees must participate in preparing for AS9100 certification and maintaining the quality management system. It is everyone’s job to ensure your customer receives the highest quality.
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Is this the only certification?
No, there are other standards available for certification. ISO 9001 is similar to AS9100 but not specifically designed for aviation, space and defense industries. AS9120 is the quality standard for parts distributors. Other common standards include ISO 14001 (environmental), ISO 45001 (health and safety) and ISO 27001 (information security).
What requirements are included?
Like ISO 9001 and AS9120, AS9100 requirements are organized into the following sections:
• Context of the Organization• Leadership• Planning• Support• Operation• Performance Evaluation• Improvement
Together, these requirements are called the Quality Management System (QMS) that are described in company documentation such as a quality manual, procedures, work instructions, records and other information. An effective QMS is one where a company follows its processes and documentation on a day-to-day basis, achieves desired results of its objectives and key performance indicators, and continually improves to perform better for its customers.
Going Beyond ISO 9001
Key additional requirements in AS9100:1. Operational risk management2. Configuration management3. Work transfers4. Prevention and detection of counterfeit parts5. Product safety6. Product quality and on-time delivery objectives7. Key process performance indicators (KPIs)8. Planning of product lifecycle9. Control of critical items/key characteristics10. Control of external processes and providers11. Monitoring of external providers12. More stringent production process controls13. Prevention and detection of foreign objects (FOD)
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Process Approach
An understanding of the AS9100 standard starts with the process approach which refers to processes and activities in your company working together to deliver quality to your customers.
What’s Required?
“The organization shall define key processes, monitor process performance and make improvements when results do not meet targets.”
Things to Remember
• A process is a set of work steps that transform parts,materials or information (inputs) into a more completeform such as assemblies, products, reports, etc. withadded value (outputs) based on specific requirements.
• The output of one process can be the input to anotherprocess. All of your company’s processes interact andaffect the final result.
• Each process is assigned a process owner who isresponsible to monitor performance (objectives andKPIs) and lead improvement of the process.
StartingPoint
EndPoint
Possible controls and check points to monitor
and measure performance
PREDECESSOR PROCESSES
e.g. at providers (internalor external) at customers,at other relevantinterested parties
MATTER, ENERGY INFORMATION
e.g. in the form of materials,resources, requirements
MATTER, ENERGY INFORMATION
e.g. in the form of product,service, decision
SUBSEQUENT PROCESSES
e.g. at customers(internal or external) atother relevantinterested parties
Inputs Outputs Receiversof Outputs
Sourcesof Inputs Activities
AS9100D Requirements:
0.3 Process Approach4.4 Quality Management System and Its Processes
Operational Risk Management
The priorities for control and improvement of your processes and QMS should be based on risk-based thinking. This approach creates a proactive culture that seeks to prevent problems and maximize improvements by setting priorities. In your company’s operations, a formal risk management process is required by AS9100.
What’s Required?
“Risks need to be identified, evaluated, and addressed to achieve targets you define and improve overall results. This helps to avoid negative results due to weaknesses and achieve better performance when possible.”
Things to Remember
• Looking for operational risks is everyone’sresponsibility and affects every company process.
• Operational risk management allows for betterplanning and improved results.
• Risk assessment is required for operational activitiessuch as product requirements review, contractnegotiations, operations management, design anddevelopment, purchasing, work transfer, etc.
AS9100D Requirements:
0.3.3 Risk-Based Thinking6.1 Actions to Address Risks and Opportunities8.1.1 Operational Risk Management
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Context of the Organization
A business does not operate in isolation. External factors such as the economy, industry trends, changes in technology, product obsolescence, new regulations and others have an impact on your business. Internal issues such as reorganization, expansion or change in ownership can also have a bearing. The AS9100 standard requires management to plan for such changes in the context of your organization which can introduce risk and opportunities to your business.
What’s Required?
“The organization shall identify external and internal issues that impact their company and its performance and determine the requirements to comply with from interested parties. These shall be considered when determining the scope of the QMS.”
Things to Remember
• External issues to consider include civil and militaryapplications, specifications from aviation authorities,differing customer needs, innovative solutions compatiblewith mature technologies, international competition andlegal environments, among others.
• Internal issues to consider include corporaterequirements, company values and culture, businessstrategy, changes in headcount, new processes andtechnologies, etc.
• Relevant interested parties and their requirementsto review:
• Customers and partners ......... > contractual agreements• Suppliers ...................................> contractual agreements• Authorities ......................................................> regulations• Certification bodies ........................................> standards• Owners, shareholders ....> applicable laws, expectations• Management, employees, unions ................. > labor laws
• The scope of the QMS defines the boundaries andapplicability of the QMS requirements in your company.
AS9100D Requirements:
4.1 Understanding the Organization and Its Context4.2 Understanding the Needs and Expectations of Interested Parties4.3 Determining the Scope of the Quality
Management System
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Leadership
The QMS is first and foremost a process led by top management in order to ensure the highest product quality and delivery performance for your customers. Leadership has hands-on responsibility for making the QMS a priority in the organization. Without management involvement, the usefulness and effectiveness of the QMS will be compromised which can put AS9100 certification in jeopardy. With clear direction and direct participation from the top leadership of the organization, the QMS can provide the control and focus needed to accomplish quality objectives and improve customer satisfaction.
What’s Required?
“Top management shall demonstrate leadership and commitment to the QMS and ensure its integration into the company’s standard business processes.”
Things to Remember
• Establishing a quality policy communicates theimportance of quality and meeting applicablerequirements.
• Defining measurable quality objectives and KPIs providesa visible yardstick of performance and improvement.
• Clarifying roles, responsibilities and authorities givesclarity for decisions, delegation and accountability.
• Being accountable for the effectiveness of the QMSinvolves management reviews, process reviews anddocument reviews by management.
• Providing resources required by the QMS includes people,equipment, infrastructure and work environment.
AS9100D Requirements:
5.0 Leadership6.2 Quality Objectives and Planning to Achieve Them7.1 Resources
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Planning
Achieving higher levels of quality requires forethought and planning based on risk management; that is, identification of likely risks and opportunities from analysis of the context of the organization, customer requirements and feedback, and overall QMS performance. Measurable quality objectives define goals and monitor progress to drive improvement in your QMS process. Planning for changes to the QMS ensures potential consequences are considered and the purpose for each change is achieved.
What’s Required?
“The organization shall ensure the proper planning needed to address risks, pursue opportunities, achieve objectives and manage change.”
Things to Remember
• Planning should be purposeful in order to achieveintended results, enhance desirable effects, prevent, orreduce, undesired effect and achieve improvement.
• Planning is an ongoing activity that involves managersand employees who have direct responsibility for theQMS and its processes.
• Assigned actions should identify tasks to complete,resources necessary, responsibilities, dates for completionand evaluation of effectiveness.
AS9100D Requirements:
6.0 Planning
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Support & Resources
Processes and resources to support the QMS is foundational for effectiveness and success. Management must ensure that sufficient people, equipment and facilities are provided in an effective work environment. Documentation should remain available and up-to-date. Measurement equipment must be protected and calibrated to ensure accuracy of results. All of these activities require planning and focus to ensure the QMS can operate properly and achieve intended results.
What’s Required?
“Resources shall be suitable to the organization and its activities (people, methods, tools, equipment, information systems, etc.”
Things to Remember
People, competence and knowledge
• Ensure sufficient human resources are available andensure needed levels of competency.
• Identify and maintain knowledge required by the business.
Awareness and communication
• Establish effective methods for communication.• Ensure employee awareness of and involvement
in the QMS.
Control of documents and records
• Control documented information that affect the QMS,including product quality and safety.
• Ensure employees are aware of changes inrelevant documentation.
Infrastructure and work environment
• Maintain needed infrastructure such as facilities,equipment, transportation resources, information andcommunication technology.
• Provide a suitable working environment for people,processes, equipment and materials.
Monitoring and measuring resources
• Identify, maintain and calibrate equipment used tomonitor/measure results.
AS9100D Requirements:
7.1.2 People7.1.3 Infrastructure7.1.4 Environment for the Operation of Processes7.1.5 Monitoring and Measuring Resources7.1.6 Organizational Knowledge7.2 Competence7.3 Awareness7.4 Communication7.5 Documented Information
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Customer Focus
Quality of products and delivery performance are essential to customers, especially in the aviation, space and defense industries. From start-to-finish, the entire QMS, must take customer needs into account. This starts with understanding customer requirements and planning needed processes, resources and materials. Throughout your operations through delivery and support open communication with customers is essential. Measurements of quality, delivery and customer satisfaction should trigger improvement actions to achieve the highest levels of performance.
What’s Required?
“The QMS is focused on customers and their needs to ensure the organization proactively meets their expectations.”
Things to Remember
• Customer satisfaction starts with understanding theirneeds and analyzing their requirements.
• The QMS must address customer and applicable statutoryand regulatory requirements.
• Top management ensures that customer satisfactionremains the focus of the QMS.
• Quality objectives and planning should supportcustomer satisfaction.
• Operational processes should be designed to protect thecustomer from receiving nonconformities andlate shipments.
• Processes for effective customer communication shouldbe established.
• Customer feedback and other relevant data should beused to determine customer satisfaction and necessaryactions for improvement of the QMS.
• Objectives for product quality and on-time delivery arerequired.
AS9100D Requirements:
5.1.2 Customer focus8.2.1 Customer communication 9.1.2 Customer satisfaction
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Operations Control
In the AS9100 standard, “operations” refers to the activities starting with the review of proposed customer requirements for the project through production to shipment and post-shipment activities. In addition to controls from ISO 9001:2015, the requirements of AS9100D include additional steps to safeguard the product based on risks to operational processes. Consideration should be given to changes throughout the product lifecycle, product safety, prevention of counterfeit parts and additional supplier and manufacturing controls, among others. These additional controls are vital due to the potential consequences of failure in the aviation, space and defense industries.
What’s Required?
“Methodologies shall be implemented for planning and controlling operations in order to meet requirements for provision of products to customers.”
Things to Remember
Configuration management
• Maintain clear identification and traceability throughoutthe product lifecycle.
• Manage configuration during changes.• Ensure documentation of product attributes is accurate.
Product safety
• Identify and mitigate safety risks related to the product.
Counterfeit parts prevention
• Purchase from original manufacturers, authorizeddistributors or other approved sources.
• Consider parts/material obsolescence in product design.• Implement testing to detect, quarantine and report
counterfeit parts.
Work transfers management
• Manage internal and external transfers of products/workto ensure continuing conformity and mitigate risk.
Special requirements, critical items, key characteristics
• Identify and control high areas of risk (e.g. newtechnology, capacity constraints, short lead-times, etc.).
• Apply special controls to materials that present significantrisk to the product.
• Have special handling and controls for critical items.• Avoid introducing variation for key characteristics.
AS9100D Requirements:
8.0 Operation8.4 Control of externally provided processes, products
and services
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Key Business Processes
In order to control the quality of product throughout the product lifecycle, several key business processes must be established, controlled and improved. These include product design, purchasing, manufacturing and post-delivery support. As appropriate to your organization and the nature of the products you produce, various processes, documentation and controls will be required.
What’s Required?
“Processes related to the product life cycle shall be organized and controlled.”
Things to Remember
Design and development
• Control product development steps including planning,reviews, verification and validation.
• Ensure product changes are managed effectively.• Consider part/material obsolescence.
Control of external providers
• Ensure adequacy of requirements communicatedto suppliers.
• Verify compliance of purchased products.• Monitor and evaluate supplier performance.• Manage risks associated with external providers.
Production, service provision, inspection and release
• Ensure proper planning and preparationof manufacturing/service provision.
• Conduct inspections and control quality.• Control the release and delivery of products to customers.• Manage production/service delivery transactions to
ensure on-time delivery within acceptable levels of riskand resource constraints.
Post-delivery support
• Provide customer assistance and product supportaccording to requirements.
AS9100D Requirements:
8.3 Design and development of products and services8.4 Control of externally provided processes, products and services8.5 Production and service provision8.6 Release of products and services8.7 Control of nonconforming outputs
Sales/Customer Support
• Identify and review customer/regulatory requirements for products and services.
• Identify and manage "special" high risk requirements.
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Performance Evaluation & Improvement
Once your AS9100D QMS is established monitoring, evaluation and improvement activities ensure that it will remain compliant with requirements and continue to meet your business needs in the future. Overall effectiveness requires continued attention and regular improvements by your top management team. Several evaluation and improvement processes are required to ensure these key activities are maintained.
What’s Required?
“The organization shall evaluate its performance, address its deficiencies and pursue opportunities for improvement.”
Things to Remember
Monitoring, measurement, analysis, and evaluation
• Implement appropriate monitoring and measurementmethods for products, processes and services.
• Ensure all operational processes have established KPIs• Analyze the results to evaluate compliance, performance,
and effectiveness.
Customer satisfaction
• Monitor and evaluate information relating to customersatisfaction including quality, delivery performance,customer complaints and requests for corrective action.
Internal audit
• Train qualified auditors.• Develop an audit program.• Audit compliance to requirements, effectiveness of
processes and QMS achieving objective and KPIresults, and effectiveness of corrective actions.
Management review
• Regularly review QMS effectiveness and alignment withstrategic direction.
• Address required inputs and outputs.
Nonconforming outputs, nonconformities and corrective actions
• Establish a process for dealing with defective products,processes or service.
• Investigate nonconformities and take corrective action toeliminate the root causes.
Continual improvement
• Implement improvements by utilizing correction,corrective action, continual improvement, breakthroughchange, innovation, and other appropriate methods.
AS9100D Requirements:
0.3.2 Plan-Do-Check-Act Cycle9.0 Performance Evaluation10.0 Improvement
LEADERSHIP(5)
RESULTS OF THE QMS
CUSTOMERSATISFACTION
PRODUCTS & SERVICES
IMPROVEMENT(10)
PERFORMANCE EVALUATION
(9)
SUPPORT (7)
OPERATION (8)
PLANNING (6)
CHECKACT
DOPLAN
QUALITY MANAGEMENT SYSTEM (4)
ORGANIZATIONAND ITS
CONTEXT (4)
CUSTOMERREQUIREMENTS
NEEDS ANDEXPECTATIONSOF RELEVANTINTERESTEDPARTIES (4)
INPUTS OUTPUTS
The AS9100D Standard
This whitepaper outlines the basics of the AS9100D standard. The diagram below illustrates the structure of this standard and its relevant clauses.
Core Business Solutions offers online and onsite consulting services to prepare you for AS9100 certification. The programs provide training, documentation, expert consulting and everything you need to be compliant with the AS9100 standard within 4 months or less.
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